Postoperative (stress) hyperglycemia in patients with no known diabetes after acute abdominal surgery MedDRA version: 24.0 Level: LLT Classification code 10042216 Term: Stress induced hyperglycemia System Organ Class: 100000004861
Conditions
Interventions
Trade Name: forxiga
Pharmaceutical Form: Capsule
INN or Proposed INN: dapagliflozin
CAS Number: 461432-26-8
Other descriptive name: DAPAGLIFLOZIN
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Ismail Gögenur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Admitted to the ward after acute abdominal surgery (ASAP patient at Slagelse Hospital, OMEGA patient at Zealand University Hospital) - At least two independent measurements of blood glucose above 7.7mmol/l within the first 48 hours after surgery - Age of 18 to 85 - Must be able to understand and sign informed content Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: - Patients diagnosed with diabetes mellitus - Impaired kidney function (eGFR < 45mL/min) - Severe liver disease (defined as transaminases above X 3 normal levels) - Acute pancreatitis within the last two months or a history of chronic pancreatitis - Participation in another pharmacological intervention trial - Predictable poor compliance (for instance mentally impaired) - Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) - Allergy to study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and feasibility of treating postoperative hyperglycemia in patients with no history of diabetes after acute abdominal surgery. ;Secondary Objective: described above;Primary end point(s): The primary endpoint is percentage of time in range (time with blood glucose level between 3.9 and 7.8mmol/l);Timepoint(s) of evaluation of this end point: Study medication must be started within 48 hours after surgery. The endpoint is monitored for 10 days after starting the medication or until discharged, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) variability of blood glucose, mean blood glucose and time with hyper/hypo glycemia 2) quality of recovery-15 questionnaire 3) immunological changes (stress response) after surgery;Timepoint(s) of evaluation of this end point: 1) monitored for 10 days after starting the medication or until discharged, whichever comes first. 2) every day while hospitalised up til 10 days of treatment 3) blood samples drawn at inclusion, on day four of treatment and when finishing treatment | — |
Countries
Denmark
Contacts
Public ContactEmilie Palmgren Colov
Department of Surgery, Slagelse Hospital
Outcome results
None listed